Some aspects of the immunotherapy of multiple sclerosis (literature review).

This article reviews some immunotherapeutic approaches, based on the concept of multiple sclerosis as a progressive autoimmune disease. A special attention is given to the experimental results building up the model of autoimmune cascade and determining the directions of pathogenic treatment. The reviewed literature data highlight the pros and cons of the results of the conducted clinical trials with immunoeffective agents: corticosteroids, nonspecific immunosuppressive and contemporary immunomodulatory agents. Attention is given to the studies of combined drug therapies and the views of contemporary investigators.

Clinico-laboratory study of methylprednisolone and cyclophosphamide treatment in patients with multiple sclerosis relapse.

INTRODUCTION: The effect of combined treatment (methylprednisolone and cyclophosphamide) of multiple sclerosis relapse within one year was investigated in an open clinical trial study of 70 patients. The sample comprised subjects shown to have clinically proven multiple sclerosis according to the criteria of C Poser and degree of neurological deficit according to EDSS rating from 2.5 to 6.0 points. MATERIAL AND METHODS: Methylprednisolone (200 mg, i.v., every other day, 10 doses, total course dose 2 g) was administered to 35 patients (mean age 31.34 +/- 1.53 years). Methylprednisolone using the same schedule and cyclophosphamide (200 mg, i.v.) given in the methylprednisolone-free day, 10 doses plus 200 mg i.v. once a month in the first three consecutive months (total course dose 2.6 g) were applied in another 35 patients (mean age 33.22 +/- 1.32 years). RESULTS AND DISCUSSION: The changes of EDSS ratings at the end of months 1 and 12, of the CD+ T-lymphocytes subpopulations and B-lymphocytes from peripheral blood--prior to treatment and between the 5th and 9th week of treatment were compared. The neurological deficit degree according to EDSS dropped significantly (P < 0.01; P < 0.001) after one month of treatment in both groups. At the end of month 12 this indicator reached its baseline value in the group treated only with methylprednisolone while remaining significantly lower in the combined therapy group (P < 0.01). After methylprednisolone and cyclophosphamide application the suppressor/inducer CD8+ T-cells increased significantly in percentage (P < 0.05), while the values of B-lymphocytes decrease significantly (P < 0.05), in contrast to the results from the methylprednisolone-only treatment. CONCLUSIONS: The results clearly indicate the greater efficaciousness of treatment by combining two immunosuppressive drugs.

Clinico-electrophysiological correlates in patients with relapsing-remitting multiple sclerosis.

INTRODUCTION: The degree of neurological deficit was evaluated in patients with multiple sclerosis (MS) relapse by the Expanded Disability Status Scale (EDSS), transcranial magnetic stimulation (TMS) and visual evoked potentials (VEPs). Clinical and electrophysiological changes before and after treatment were compared in an attempt to find significant associations between the indicators of disease activity. MATERIAL AND METHODS: In all the patients (n = 35, mean age 32.05 +/- 2.67 years) EDSS rating was assessed prior to and 2 months after the beginning of treatment with methylprednisolone (MP)--13 patients, and with MP in combination with cyclophosphamide (CPH)--22 patients. Transcranial magnetic stimulation with measuring central latency time (CLT) was performed in 20 patients (mean age 30.85 +/- 8.01 years) before and at the end of the 2nd month after treatment with MP independently (9 patients) and MP combined with CPH (11 patients). In another 15 patients with a mean age of 33.67 +/- 7.45 years VEPs are examined (P100 latency) before and on the 2nd month after treatment with MP (4 patients) and MP combined with CPH (11 patients). RESULTS: CLT (P < 0.001) and P100 (P < 0.001) were significantly shortened after treatment in comparison with the baseline values. A significant correlation (P < 0.05) between CLT and the pyramid subscale was found. CONCLUSION: The results suggests that CTL and P100 reflect the effect of treatment on the intensity of the pathological process, the CLT correlating with the severity of the pyramid deficit according to EDSS rating in the course of the treatment.

Regional differences in diabetic patients' pharmacotherapy in Bulgaria.

BACKGROUND: The regional analyses play an important role in understanding a state of diabetes mellitus management and to support informed policy options. They need to be explored in more details in order to ensure an equal patients' access to health care services of the same value and quality. AIM: The aim of this study is to analyze regional differences in a cost of diabetes therapy for insulin users in Bulgaria. MATERIALS AND METHODS: It is a combined prospective and retrospective observational study with duration of 6 months. Diabetic patients on insulin therapy were recruited by 35 endocrinologists. Information about the health care resources used was collected within 3-prospective and 3 retrospective months in 2010 and 2011. The regional cost of illness analysis was performed by calculating the average cost attributable to each individual patient despite the fact that some might not use a particular health care resource. Subgroup analysis was performed for hospitalized patients. RESULTS: A detailed analysis revealed cost differences in the regions, especially with more vulnerable population like Burgas and Pleven regions. Another reason for the cost differences is the type of insulin or type of therapy. Our study confirms the fact that the hospitalizations are the major cost driver. Rising diabetes prevalence and associated costs, including hospitalizations and management of diabetes complications, are a growing concern. The last possible reason for regional differences is the patients' characteristics and therapy differences. We add evidence demonstrating that the patients on insulin and OAD consume more resources including hospitalizations and suffer from more complications of diabetes. CONCLUSIONS: Reasons for regional differences might have different origin as there are various population characteristics, type of therapy, socio economic status and others.